Next-Generation Synbiotic in Individuals With Overweight or Obesity

Status Not yet recruiting

Clinical Trial Summary

This study plans to evaluate the effect of consuming a symbiotic (probiotic + prebiotic) for 3 months on body weight, body composition, glucose sensitivity, and psychological parameters, as well as on gut and blood microbial composition. Synbiotic consumption is preceded by a 3-day antibiotic course to help ensure the opening of new niches (houses) for the upcoming beneficial bacteria.

Clinical Trial Description

This is a triple-blinded, randomized clinical trial in which participants will be allocated to one of two groups: 1) 3-day antibiotic followed by synbiotic consumption for 3 months or 2) 3-day antibiotic followed by placebo consumption for 3 months. Blood and stool samples will be collected before the antibiotic, and before and after the symbiotic intervention in both groups. Gut microbial composition will be analyzed through whole genome sequencing and blood microbial composition through 16S rRNA. Glucose sensitivity will be measured through fasting glucose, fasting insulin, and HbA1c. Body composition through DXA and BodPod will be measured before and after the symbiotic intervention. Psychological questionnaires such as the Beck Anxiety and the Beck Depression Inventories, as well as the RED-9 questionnaire to respectively measure anxiety, depression, and food cravings, will be applied before and after the symbiotic intervention. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06213480
Study type	Interventional
Source	Texas Christian University
Contact	Elisa Marroquin, Ph.D.
Phone	817-257-1031
Email	E.Marroquin@tcu.edu
Status	Not yet recruiting
Phase	N/A
Start date	January 10, 2024
Completion date	May 20, 2025

View Details

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